immunogenicity and safety of gsk biologicals' boostrix polio vaccine in 3 and 4-year-old children

Conditions: Acellular Pertussis; Poliomyelitis; Tetanus; Diphtheria

Summary: the purpose of the study is to compare the immunogenicity and safety of a booster dose of boostrixtm polio to that of sanofi pasteur msd's repevaxtm, when co-administered with a second dose of priorixtm, in healthy 3 and 4-year-old children.


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that their parent(s)/legally acceptable representative(s) (lar) can and will comply with the requirements of the protocol should be enrolled in the study. * a male or female child of 3 or 4 years of age at the time of booster vaccination (up to, but excluding 5 years of age). * subjects who have received a complete three-dose primary vaccination with diphtheria-tetanus-acellular pertussis (dtpa) vaccine and inactivated poliovirus (ipv) vaccine in the first six months of life, in line with recommendations in the united kingdom (uk). * subjects who received a first dose of a live attenuated measles-mumps-rubella vaccine within the second year of life, in line with recommendations in the uk. * written informed consent obtained from the parent(s)/lar(s) of the subject at the time of enrolment. * healthy subjects as established by medical history and clinical examination before entering into the study. exclusion criteria: * child in care. * use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the booster dose of study vaccine, or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose. * administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination, or planned administration during the study period, with the exception of inactivated influenza vaccine. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis since primary vaccination in the first year of life. * previous measles, mumps and/or rubella second dose vaccination. * evidence of previous or intercurrent diphtheria, tetanus, pertussis, poliomyelitis, measles, mumps and/or rubella disease. * known exposure to measles, mumps and/or rubella within 30 days prior to study start. * any confirmed or suspected immunosuppressive or immunodeficiency condition, based on medical history and physical examination. * history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine. * administration of immunoglobulin and/or any blood products within the three months preceding the booster dose or planned administration during the study period. * occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation. * occurrence of any of the following adverse events after a previous administration of a dtp vaccine: * hypersensitivity reaction to any component of the vaccine; * encephalopathy of unknown aetiology occurring within 7 days following previous vaccination with pertussis-containing vaccine; * fever \>= 40°c within 48 hours of vaccination, not due to another identifiable cause; * collapse or shock-like state within 48 hours of vaccination; * convulsions with or without fever, occurring within 3 days of vaccination. * acute disease and/or fever at the time of enrolment or within 24 hours of study vaccine administration.

Keywords: mmr dtpa-ipv boostrix polio repevax priorix